Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease
- Conditions
- HyperkalemiaResistant Hypertension
- Interventions
- Registration Number
- NCT03071263
- Lead Sponsor
- Relypsa, Inc.
- Brief Summary
The purpose of this study is to determine if patiromer treatment in chronic kidney disease (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will result in more persistent use of spironolactone through prevention of hyperkalemia and lead to improved blood pressure control compared with treatment with spironolactone alone (placebo).
- Detailed Description
Approximately 290 eligible participants with \[chronic kidney disease (CKD) on stable doses of medication\] will be randomly assigned to receive a patiromer or placebo starting dose of two packets a day, once a day.
All eligible participants will undergo a screening/run-in period (up to 4 weeks) to determine eligibility for study entry. Eligible participants will be randomized and treated for 12 weeks (Treatment Period) and followed for 2 weeks after completing the patiromer or placebo treatment. There are 8 planned clinic visits during the Treatment Period and one planned visit two weeks after the last dose of patiromer or placebo (Follow-up Period).
The dose of patiromer or placebo may be increased or decreased (titrated) based on participants' individual potassium response.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 295
- Age ≥ 18 years
- Taking at least three medications for blood pressure (one a diuretic)
- Uncontrolled high blood pressure
- Abnormal kidney function (with-eGFR, a measure of kidney function, of 25 - ≤ 45 mL/min/1.73m2
- Normal Blood serum Potassium in a specific range (4.3 - 5.1 mEq/L)
- History of untreated known causes of high blood pressure, excluding kidney disease (not CKD)
- Inability to measure BP
- Not taking high blood pressure medications as prescribed medications
- Recent change in renal function (in the past 3 months) which has required hospitalization or dialysis
- Renal transplant
- History of cancer within past 12 months
- Recent cardiovascular event with last 3 months
- Clinically significant abnormalities of heart rhythm (ventricular arrhythmia or atrial fibrillation with uncontrolled heart rate)
- Inability to take study medication
- Alcoholism
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 - Placebo Placebo spironolactone + blinded placebo Group 2 - Placebo Spironolactone spironolactone + blinded placebo Group 1 - Patiromer Patiromer spironolactone + blinded patiromer Group 1 - Patiromer Spironolactone spironolactone + blinded patiromer
- Primary Outcome Measures
Name Time Method Number of Participants Remaining on Spironolactone at Week 12 At week 12 The proportion of subjects remaining on spironolactone at Week 12 will be compared between treatment groups (spironolactone/patiromer versus spironolactone/placebo). Subjects who discontinued from the study early or discontinued study spironolactone prior to Week 12, for any reason, were considered as not having remained on spironolactone until Week 12.
- Secondary Outcome Measures
Name Time Method Change in AOBP SBP From Baseline to Week 12 or Last Available AOBP SBP Prior to Addition of Any New BP Medications or Increase From Any Baseline BP Medications From baseline to Week 12 AOBP: Automated Office Blood Pressure SBP: Systolic Blood Pressure BP: Blood Pressure
Trial Locations
- Locations (40)
Investigator Site 1402
🇧🇬Sofia, Bulgaria
Investigator Site 1022
🇺🇸Chicago, Illinois, United States
Investigator Site 1023
🇺🇸Miami Lakes, Florida, United States
Investiagor Site 2205
🇭🇷Zagreb, Croatia
Investigator Site 3807
🇬🇪Tbilisi, Georgia
Investigator Site 2203
🇭🇷Zagreb, Croatia
Investigator Site 8202
🇬🇧Leicester, United Kingdom
Investigator Site 8205
🇬🇧London, United Kingdom
Investigator Site 1012
🇺🇸Hollywood, Florida, United States
Investigator Site 2201
🇭🇷Zagreb, Croatia
Investigator Site 3806
🇬🇪Tbilisi, Georgia
Investigator Site 3802
🇬🇪Tbilisi, Georgia
Investigator Site 3811
🇬🇪Tbilisi, Georgia
Investigator Site 3812
🇬🇪Tbilisi, Georgia
Investigator Site 3805
🇬🇪Tbilisi, Georgia
Investigator Site 3810
🇬🇪Tbilisi, Georgia
Investigator Site 3801
🇬🇪Tbilisi, Georgia
Investigator Site 3813
🇬🇪Tbilisi, Georgia
Investigator Site 3804
🇬🇪Tbilisi, Georgia
Investigator Site 3808
🇬🇪Tbilisi, Georgia
Investigator Site 3809
🇬🇪Tbilisi, Georgia
Investigator Site 4607
🇭🇺Balatonfured, Hungary
Investigator Site 7805
🇺🇦Kiev, Ukraine
Investigator Site 4202
🇩🇪Gottingen, Germany
Investigator Site 4601
🇭🇺Hatvan, Hungary
Investigator Site 4606
🇭🇺Budapest, Hungary
Investigator Site 4611
🇭🇺Debrecen, Hungary
Investigator Site 4602
🇭🇺Miskolc, Hungary
Investigator Site 7403
🇿🇦Johannesburg, South Africa
Investigator Site 7803
🇺🇦Khar'kov, Ukraine
Investiagor Site 7809
🇺🇦Kharkiv, Ukraine
Investigator Site 4610
🇭🇺Miskolc, Hungary
Investigator Site 4608
🇭🇺Mosonmagyarovar, Hungary
Investigator Site 7801
🇺🇦Kiev, Ukraine
Investigator Site 7802
🇺🇦Kharkiv, Ukraine
Investigator Site 7804
🇺🇦Zaporizhzhia, Ukraine
Investigator Site 7807
🇺🇦Zaporizhzhia, Ukraine
Investigator Site 4605
🇭🇺Kistarcsa, Hungary
Investigator Site 2202
🇭🇷Zagreb, Croatia
Investigator Site 7808
🇺🇦Kharkiv, Ukraine